Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Insulin glargine (HOE901)
Insulin glargine (HOE901)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion criteria:
- Male or female subjects with diabetes mellitus type 1 for more than one year,
- Total insulin dose of <1.2 U/kg/day,
- Glycohemoglobin (HbA1c) ≤ 9.0%,
- Fasting negative serum C-peptide (< 0.3 nmol/L),
- Stable insulin regimen for at least 2 months prior to study,
- Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab,
- Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.
Exclusion criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness,
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months,
- Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month),
- Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position,
- Presence or history of a drug allergy or clinically significant allergic disease,
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol,
- Pregnant or breast feeding women,
- Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days,
- Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab),
- Known hypersensitivity to insulin glargine and excipients,
- Any history or presence of deep leg vein thrombosis.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin glargine / New insulin glargine formulation
Arm Description
Period 1: Insulin glargine Period 2: New insulin glargine formulation Period 3: New insulin glargine formulation Period 4: New insulin glargine formulation Duration of treatment: 1 day at each period
Outcomes
Primary Outcome Measures
The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)
Secondary Outcome Measures
The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -
Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)
Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)
Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)
Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01195454
Brief Title
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus®
Secondary Objectives:
To assess the exposure ratios of a new insulin glargine formulation versus Lantus®
To compare the duration of action of a new insulin glargine formulation versus Lantus®
To explore the dose response and dose exposure relationship of a new insulin glargine formulation
To assess the safety and tolerability of a new insulin glargine formulation
Detailed Description
The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows:
Screening: 3 to 28 days
Treatment period: 1 to 4 days: 2 days (1 overnight stay)
Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)
End of study: 1 day after the last dosing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin glargine / New insulin glargine formulation
Arm Type
Experimental
Arm Description
Period 1: Insulin glargine
Period 2: New insulin glargine formulation
Period 3: New insulin glargine formulation
Period 4: New insulin glargine formulation
Duration of treatment: 1 day at each period
Intervention Type
Drug
Intervention Name(s)
Insulin glargine (HOE901)
Intervention Description
Pharmaceutical form: Lantus solution for injection
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin glargine (HOE901)
Intervention Description
Pharmaceutical form: New insulin glargine formulation solution for injection
Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)
Time Frame
36 hours (D1 to D2) in all four treatment periods
Secondary Outcome Measure Information:
Title
The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -
Time Frame
36 hours (D1 to D2) in all four treatment periods
Title
Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)
Time Frame
36 hours (D1 to D2) in all four treatment periods
Title
Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)
Time Frame
36 hours (D1 to D2) in all four treatment periods
Title
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)
Time Frame
36 hours (D1 to D2) in all four treatment periods
Title
Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)
Time Frame
36 hours (D1 to D2) in all four treatment periods
Title
Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)
Time Frame
36 hours (D1 to D2) in all four treatment periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male or female subjects with diabetes mellitus type 1 for more than one year,
Total insulin dose of <1.2 U/kg/day,
Glycohemoglobin (HbA1c) ≤ 9.0%,
Fasting negative serum C-peptide (< 0.3 nmol/L),
Stable insulin regimen for at least 2 months prior to study,
Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab,
Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.
Exclusion criteria:
Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness,
More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months,
Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month),
Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position,
Presence or history of a drug allergy or clinically significant allergic disease,
Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol,
Pregnant or breast feeding women,
Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days,
Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab),
Known hypersensitivity to insulin glargine and excipients,
Any history or presence of deep leg vein thrombosis.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
12. IPD Sharing Statement
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Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
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